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The Role of TVSG and HS in Determining Endometrial Pathologies

Primary Purpose

Abnormal Uterine Bleeding

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Transvaginal ultrasound

Hysteroscopy

About this trial

This is an interventional diagnostic trial for Abnormal Uterine Bleeding focused on measuring transvaginal ultrasonography, hysteroscopy, abnormal uterine bleeding

Eligibility Criteria

21 Years - 51 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

patients who have no history of hysteroscopy and curettage,
patients who have no history of ovulatory dysfunction
women who have active vaginal bleeding.

Exclusion Criteria:

presence of genital infections/PID
presence of pregnancy
presence of vaginal or cervical pathology causing vaginal bleeding
women who are receiving hormonal treatment (COC/HRT)
patients formerly diagnosed with endometrial pathology
patients having coagulopathy
women who are using intrauterine device.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Transvaginal ultrasound

Hysteroscopy

Arm Description

Transvaginal ultrasound was applied 216 women with abnormal uterine bleeding.The transvaginal ultrasound diagnoses were compared with the received endometrial samples.

Hysteroscopy was also performed under general anesthesia.Hysteroscopy was performed by a single operator (NNY).The operator and two supervising endoscopists were blinded to the ultrasound results.After the hysteroscopy, endometrial sampling was also done. The diagnoses were compared with the received endometrial samples.

Outcomes

Primary Outcome Measures

accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy

The main outcome variable of the study was accuracy of diagnostic performance of transvaginal ultrasonography and hysteroscopy in premenopausal and menopausal women with abnormal uterin bleeding .

Secondary Outcome Measures

Full Information

NCT ID

NCT03441087

First Posted

February 15, 2018

Last Updated

February 22, 2018

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03441087

Brief Title

The Role of TVSG and HS in Determining Endometrial Pathologies

Official Title

Ultrasound and Hysteroscopy's Place on the Diagnosis of Abnormal Uterin Bleeding

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2011 (Actual)

Primary Completion Date

December 31, 2011 (Actual)

Study Completion Date

December 31, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Although hysteroscopy (HS) and transvaginal ultrasonography (TVSG) are methods in the diagnosis of AUB, there is some suspicion about their efficacy. The aim of this study was to determine the efficacy and safety of HS and TVSG on diagnosing abnormal uterine bleeding(AUB) .216 women admitted to the investigators clinic (Sisli Ethal Training and Research Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 21-51 years of age. These patients were divided into two groups; menopause (71women) and pre-menopause (145 women). HS and endometrial sampling were performed both groups after TVSG.The success of these methods was assessed by kappa analysis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abnormal Uterine Bleeding

Keywords

transvaginal ultrasonography, hysteroscopy, abnormal uterine bleeding

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Non-Randomized

Enrollment

216 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transvaginal ultrasound

Arm Type

Other

Arm Description

Transvaginal ultrasound was applied 216 women with abnormal uterine bleeding.The transvaginal ultrasound diagnoses were compared with the received endometrial samples.

Arm Title

Hysteroscopy

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Transvaginal ultrasound

Intervention Type

Device

Intervention Name(s)

Hysteroscopy

Primary Outcome Measure Information:

Title

accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy

Description

The main outcome variable of the study was accuracy of diagnostic performance of transvaginal ultrasonography and hysteroscopy in premenopausal and menopausal women with abnormal uterin bleeding .

Time Frame

up to 12 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

51 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients who have no history of hysteroscopy and curettage, patients who have no history of ovulatory dysfunction women who have active vaginal bleeding. Exclusion Criteria: presence of genital infections/PID presence of pregnancy presence of vaginal or cervical pathology causing vaginal bleeding women who are receiving hormonal treatment (COC/HRT) patients formerly diagnosed with endometrial pathology patients having coagulopathy women who are using intrauterine device.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nefise Nazlı YENIGUL, MD

Organizational Affiliation

Sisli Etfal Research and Training hospital, Obstetrics and gynecology department Istanbul, Marmara Turkey

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

The Role of TVSG and HS in Determining Endometrial Pathologies

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